Completed

A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MenACWY-CRM

Biological
Who is being recruted

Bacterial Infections and Mycoses+3

+ Bacterial Infections

+ Infections

From 2 to 10 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 7, 2012

Actual date on which the first participant was enrolled.

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Official TitleA Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.
NCT01682876
Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

715 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial Infections

Criteria

Inclusion Criteria: * Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations Exclusion Criteria: 1. Unwilling or unable to give written informed assent or consent to participate in the study. 2. Perceived to be unreliable or unavailable for the duration of the study period. 3. Previous confirmed or suspected disease caused by N. meningitidis. 4. Previously immunized with a meningococcal vaccine (licensed or investigational). 5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. 6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine. (certain exceptions influenza vaccines apply) 7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment. 8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components 10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy, * receipt of immunostimulants, * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives. 11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Subjects 2 through 5 years received one vaccination of MenACWY-CRM

Group II

Active Comparator
Subjects 2 through 5 years received two vaccinations of MenACWY-CRM

Group III

Placebo
Subjects 6 through 10 years received one vaccination of MenACWY-CRM

Group IV

Active Comparator
Subjects 6 through 10 years received two vaccinations of MenACWY-CRM

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

GSK Investigational Site

Birmingham, United StatesOpen GSK Investigational Site in Google Maps
Suspended

GSK Investigational Site

Sacramento, United States
Suspended

GSK Investigational Site

Lake Mary, United States
Suspended

GSK Investigational Site

Marietta, United States
Completed19 Study Centers